Frequently asked questions
When does the regulation come into force?
The regulation will only become applicable once it has been verified that the EU portal and the EU database are fully functional. This is anticipated to be during the first half of 2019.
Does this regulation apply to studies conducted outside the EU?
The regulation applies to any clinical trial that includes patients from at least one EU member state.
Must we include all ten elements outlined in Annex V of the regulation document?
Yes, inclusion of the ten sections is mandatory, however there is a degree of flexibility regarding the order of these sections and the reporting of the sub-sections within each of the ten sections.
Where should the lay summary be submitted once complete?
The lay summary should be submitted to the EU online portal. This is not yet complete, however once complete a link to the portal will be made available here.
Whose responsibility is it to ensure the lay summary is submitted to the portal?
It is the responsibility of the trial sponsor to ensure that the lay summary is developed and submitted to the EU portal/database within the required timelines.
What is the timeline for submitting the lay summary once the trial has completed?
Irrespective of the outcome of the clinical trial, within one year from the end of the clinical trial in all Member States concerned, the sponsor shall submit to the EU portal/database a summary of the results of the clinical trial.
How is a ‘clinical trial’ defined by the regulation?
‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
Is there a limit to the size of the lay summary document?
There is no limit placed on the size of the lay summary document (to be submitted as a PDF). However, it should be as succinct as possible while relaying the required information in a way that is readily understandable.
How do we ensure that the lay summary is pitched at an appropriate reading level?
The lay summary text should be suitable for people with a low to average level of literacy (e.g. a 6th grade student’s reading ability). We use a software-based language-specific reading test to assess the literacy level of each lay summary.
Are lay summaries considered to be promotional documents?
No, lay summaries are regulatory documents, and thus non-promotional. The lay summary should remain factual and objective, avoiding any promotional language or promotional perception through formatting or tone.
Into which languages should the lay summaries be translated?
As a minimum, the summary is expected to be provided in the local language of each of the EU countries where the trial took place. We are able to support in providing translations of your lay summary.
Are lay summaries required for medical device-related trials?
The regulation only applies to clinical trials on medicinal products for human use. As such, lay summaries are not required for trials involving medical devices.
Why not use my existing regulatory or medical communications agency to develop the lay summary?
Most traditional regulatory or medical communications agencies focus on communication of high-level scientific information to like-minded professionals (doctors, academics, regulators, etc.). Their mind-set is therefore not attuned to developing content understandable to a lay audience. Lay summaries ltd have the scientific understanding as well as the skills, knowledge, and experience to communicate complex scientific concepts in a way that is understandable to the person on the street.